Efficacy and safety of peginterferon alfa-2b plus ribavirin for HCV-positive mixed cryoglobulinemia: a multicentre open-label study

Mazzaro, C.; Monti, G.; Saccardo, F.; Zignego, Anna Linda; Ferri, C.; De Vita, S.; Gabrielli, A.; Lenzi, M.; Donada, C.; Galli, M.; Pietrogrande, M.; Pozzato, G.

OBJECTIVES: The aim of the present study is to provide information on clinical outcome of the patients affected by HCV-positive mixed cryoglobulinemia (MC) treated with PEG-IFN and Ribavirin for 6 or 12 months according to the HCV genotype. METHODS: Eighty-six patients (42 women and 44 men) were enrolled in 8 Italian centres. All the patients had MC in the active phase of the disease. The patients received Peginterferon alfa-2b 1.5 mcg/kg/once a week (QW) and daily oral Ribavirin (800/1,000/1,200) according to their body weight for 48 weeks for genotype 1 and 4 and for 24 weeks for genotypes 2 and 3. RESULTS: In the 44 patients who underwent 12 months of therapy, 17 cases (39%) could be considered as 'non-responders' and 11 relapsed, therefore only 16 patients (36%) obtained a sustained virological response. In the 42 patients who underwent six months of therapy only 7 cases (17%) could be considered as 'non-responders' and 8 relapsed, therefore 27 patients (64%) obtained a sustained virological response. Purpura score dropped in both group (p<5.79 x 10-17) and only 5 cases of the group A (11%) and 5 of the group B (12%) did not show any improvement. Arthralgias showed a similar behaviour. Many patients relapsed after the end of the treatment. CONCLUSIONS: This study documents a lower response rate than that observed in the clinical trials with HCV chronic hepatitis, but the presence of comorbidities and older age should be taken into consideration. Most patients (88.5%) showed a complete and persistent recovery from clinical symptoms.

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Titolo:	Efficacy and safety of peginterferon alfa-2b plus ribavirin for HCV-positive mixed cryoglobulinemia: a multicentre open-label study
Autori di Ateneo:	C. Mazzaro G. Monti F. Saccardo ZIGNEGO, ANNA LINDA C. Ferri S. De Vita A. Gabrielli M. Lenzi C. Donada M. Galli M. Pietrogrande G. Pozzato mostra contributor esterni nascondi contributor esterni
Autori:	C. Mazzaro; G. Monti; F. Saccardo; ZIGNEGO, ANNA LINDA; C. Ferri; S. De Vita; A. Gabrielli; M. Lenzi; C. Donada; M. Galli; M. Pietrogrande; G. Pozzato
Data di pubblicazione:	2011
Rivista:	CLINICAL AND EXPERIMENTAL RHEUMATOLOGY
Volume:	29
Pagina iniziale:	933
Pagina finale:	941
Abstract:	OBJECTIVES: The aim of the present study is to provide information on clinical outcome of the patients affected by HCV-positive mixed cryoglobulinemia (MC) treated with PEG-IFN and Ribavirin for 6 or 12 months according to the HCV genotype. METHODS: Eighty-six patients (42 women and 44 men) were enrolled in 8 Italian centres. All the patients had MC in the active phase of the disease. The patients received Peginterferon alfa-2b 1.5 mcg/kg/once a week (QW) and daily oral Ribavirin (800/1,000/1,200) according to their body weight for 48 weeks for genotype 1 and 4 and for 24 weeks for genotypes 2 and 3. RESULTS: In the 44 patients who underwent 12 months of therapy, 17 cases (39%) could be considered as 'non-responders' and 11 relapsed, therefore only 16 patients (36%) obtained a sustained virological response. In the 42 patients who underwent six months of therapy only 7 cases (17%) could be considered as 'non-responders' and 8 relapsed, therefore 27 patients (64%) obtained a sustained virological response. Purpura score dropped in both group (p<5.79 x 10-17) and only 5 cases of the group A (11%) and 5 of the group B (12%) did not show any improvement. Arthralgias showed a similar behaviour. Many patients relapsed after the end of the treatment. CONCLUSIONS: This study documents a lower response rate than that observed in the clinical trials with HCV chronic hepatitis, but the presence of comorbidities and older age should be taken into consideration. Most patients (88.5%) showed a complete and persistent recovery from clinical symptoms.
Handle:	http://hdl.handle.net/2158/655347
Appare nelle tipologie:	1a - Articolo su rivista

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